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United States · US · US:0002-4815_01706851-8b56-40b8-9e22-e454b3e24f95

Verzenio

Orange BookUNIISPLATC L01EF03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeL01EF03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0002481554
    1 BLISTER PACK in 1 CARTON (0002-4815-54) / 14 TABLET in 1 BLISTER PACK
  • ndc11
    0002481562
    2 BLISTER PACK in 1 CARTON (0002-4815-62) / 14 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
60UAB198HK
ABEMACICLIB
RxCUI 1946825
Orange Book
N208716
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "60UAB198HK",
    "rxcui": "1946825",
    "inchikey": "UZWDCWONPYILKI-UHFFFAOYSA-N",
    "display_name": "ABEMACICLIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "be4bc0de-0fdc-4d46-8d25-be43c79e6a06": {
      "match": "brand_token",
      "title": "VERZENIO (ABEMACICLIB) TABLET [ELI LILLY AND COMPANY]",
      "spl_version": "27",
      "published_date": "2025-08-29"
    }
  },
  "productid": "0002-4815_01706851-8b56-40b8-9e22-e454b3e24f95",
  "productndc": "0002-4815",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208716",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Sep 28, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Sep 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ABEMACICLIB",
  "proprietary_name": "Verzenio",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208716",
  "marketing_category": "NDA",
  "nonproprietary_name": "abemaciclib",
  "start_marketing_date": "20170928",
  "active_numerator_strength": "100"
}

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